Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Photo opp: How imaging companies focused on cell and gene therapies

Fujifilm and Nikon say their respective moves into regenerative medicine came from a rich heritage in imaging services such as X-rays and microscopes.

In January 2018, Fujifilm Corporation, through its contract development and manufacturing organization (CDMO) business Fujifilm Diosynth Biotechnologies (FDB), opened an 80,000 square-foot facility in Texas for the production of clinical and commercial gene therapies. Months later it announced plans to expand the site, adding gene therapy fill/finish capabilities.

Investments in such an innovative field as gene therapies show the firm, often associated with photography, has come a long way from its aim of being the first Japanese firm to produce photographic film back in the 1930s.

Fujifilm: one of several imaging firms to have evolved into healthcare and regenerative medicines. Image: iStock/luchschen

According to the firm, which only began offering CDMO services in 2011, the move into regenerative medicines has not been a “natural jump” but rather an evolution to the company’s goal to advance healthcare.

“This goes way back to 1936 when we launched our healthcare business with X-ray film,” a spokesperson from the company told BioProcess Insider.

“From then to today we have continued to evolve, from digital radiography, endoscopy, ultrasound systems, minimally invasive surgery and healthcare IT to pharmaceuticals, biopharmaceuticals, cell culture media and regenerative medicine.”

This is where entering the gene therapy space comes into play, as “gene therapies require a certain level of expertise and capabilities in both development and manufacturing,” we were told.

“A good example of this is Fujifilm’s advanced drug delivery technologies that use nano-particles designed to target diseases. The culture and know-how behind highly-skilled manufacturing of complex process of color film manufacturing, which requires precisely arranging over 100 types of compounds across 20 photosensitive layers in a thickness measuring just 20 microns, has allowed the company to be leader in the drug delivery space.”

“The same is happening in the gene therapy manufacturing space. The application of know-how from all these other areas are easily translatable to the cGMP production of complex therapeutics such as gene therapies.”

Nikon

Fellow Japanese firm Nikon Corporation is also synonymous with photography but has been operating in the healthcare field since 2005.

However, a partnership with Swiss CDMO Lonza in 2015 gave newly formed subsidiary Nikon CeLL innovation Co., Ltd access to quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly owned Nikon cell and gene therapy contract manufacturing business.

Image: Wikimedia Commons/Nikon Polska

“Lonza wanted a Japanese partner and Nikon wanted to enter into the [cell and gene therapy] field,” Kim Raineri, VP of Operations at Nikon CeLL innovation told this publication. “That was the birth. We established a facility in Japan, in Tokyo to really become the premier provider of cell and gene manufacturing services.”

However, Nikon’s photographic and imaging heritage put the firm in a robust position to thrive in this field, he continued.

“Nikon’s microscope division has a long history in participating in cell culture activity. There’s a research group focuses around stem cells, and work on other products such as the BioStation – a cell culture observation system launched in 2007 – which does real time monitoring of cell culture applications.

“So it was not a huge step, but it was a step in establishing a CDMO with a good partner like Lonza. I believe it is Nikon’s desire that it can deploy some of these technologies into the cell and gene therapy space as the field continues to grow,” Raineri continued. “Vision technology, real time monitoring of cell culture is an area which is not well developed and there are opportunities there that can be seized upon, and Nikon is in a good position.”

Consumer electronics and biopharma

Another photography firm, Olympus Corporation, also had a stake in biopharma up until February 2014 when Olympus Biotech ended its operations. The firm’s New Hampshire facility was later snapped up by Danish biopharma firm Novo Nordisk.

Meanwhile, there is a large crossover between the electronics industry and the biopharma space.

Samsung, through its Samsung BioLogics business, is one major example looking to compete with traditional CDMOs such as Lonza and Boehringer Ingelheim. Other examples include LG Corporation, which also has a life sciences division, and Sony which manufactures a range of flow cytometry reagents and pharma imaging instruments.